Breckenridge Pharmaceutical, Inc recalls Duloxetine Delayed-Release Capsules USP, 60 mg, 1000-count bottles, Rx Only, Manufactured by Towa Pharmaceutical Europe,
Recalled April 30, 2025 · FDA recall D-0387-2025 · Breckenridge Pharmaceutical
Hazard
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit. · FDA Class II
Units
16,473 bottles
Sold at
US Nationwide.
Description
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Product
Duloxetine Delayed-Release Capsules USP, 60 mg, 1000-count bottles, Rx Only, Manufactured by Towa Pharmaceutical Europe, S.L., Distributed by Breckenridge Pharmaceutical, Inc. Berkeley Heights, NJ 07922, NDC# 51991-748-10
Manufacturer(s)
Breckenridge Pharmaceutical, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →